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Kinesio Tex Tape in Reducing Edema and Seroma After Complex Reconstructive Breast Surgery (BREASTAPE)

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ClinicalTrials.gov Identifier: NCT03477565
Recruitment Status : Unknown
Verified March 2018 by Stefano Martella, IRCCS San Raffaele.
Recruitment status was:  Not yet recruiting
First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Stefano Martella, IRCCS San Raffaele

Brief Summary:

Over the last two decades in the field of oncology, the prevention, diagnosis, treatment and rehabilitation have reached a remarkable development, improving healing rates and reducing the number of deaths from cancer. The most frequent cancer in the female population is the breast one, which consequences can become disabling. In recent years, surgeons need to find more effective and less invasive treatments. Nowadays, despite the achievements, oncological surgery can cause side effects that cannot allow the return to normal life. Some of these problems are represented by the formation of edema and seroma, which can be handled by the physiotherapist through the manual lymphatic drainage and the application of an elastic tape. The elastic tape is used a lot in clinical practice, despite it lacks supportive evidence.

The primary aim of the study is to verify the effectiveness of Kinesio Tex Tape in reducing edema and seroma formation following complex reconstructive breast surgery. The secondary goals are the evaluation of the quality of the scar, of the perception of pain, of the degree of satisfaction and disability.

It is a controlled, monocentric, national, comparative, randomized, single-blind study. The sample size is 60 patients who undergo complex reconstructive breast surgery. Patients are divided into two groups: the experimental one (receiving standard treatment and Kinesio Tex Tape application) and a group of control (just receiving standard treatment). To evaluate edema and seroma, ultrasound is used; ultrasounds will be on the 1st, 15th and 30th postoperative days (T0, T1 and T2); Vancouver Scar Scale is used to define the quality of the scar (T0 and T2); to measure the subjective perception of pain and to evaluate the degree of patient satisfaction, two VAS scales are administered (the VAS scale for pain is administered at T0, T1 and T2, while the VAS scale for satisfaction is given at T1 and T2); Finally, to assess the degree of disability, the DASH Questionnaire is used (T0, T1 and T2).


Condition or disease Intervention/treatment Phase
Breast Cancer Mastectomy Breast Implantation Edema Seroma Device: Kinesio tape lymphatic drainage technique application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Kinesio Tex Tape Application in Reducing Edema and Seroma Formation Following Complex Reconstructive Breast Surgery
Estimated Study Start Date : April 3, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Sperimental group

Patients who belong to the sperimental group ("SPER") will receive the standard treatment and Kinesio tape lymphatic drainage technique application.

The experimental group also receives the expected standard treatment, consisting in physiotherapeutic evaluation and physiotherapy counseling.

Device: Kinesio tape lymphatic drainage technique application
Kinesio Tex Tape strips are applied following Dr.Kase draining techinique. The choice of tape's length and strips' number is based on the area of breast edema and/or presence of seroma, which must be completely covered. The patch is cut into fan strips. The major base is positioned near the functioning lymph node stations closest to the edema and/or seroma area. The bases and the tails of the fan must be applied with zero tension, while for the central part is reached 15-25% of tension. The first application takes place on the 1st post-operative day, while the second is performed on the 7th post-operative day. In case the tape is detached from one application to another, it is necessary that the patient resume in the clinic for a new application to ensure continuity of the therapeutic effect; otherwise the patient is eliminated from the study. The experimental group also receives the expected standard treatment, consisting in physiotherapeutic evaluation and counselin.
Other Names:
  • Kinesio Tape
  • Kinesiotape
  • Kinesio Tapes
  • Kinesio Taping
  • Kinesiology Taping

No Intervention: Control group
Patients who belong to the control group ("CONTR") will receive only the standard treatment. Standard treatment consists in physiotherapy evaluation and counseling. The educational part, the demonstration of the exercises and the prosthesis mobilization are included in this treatment.



Primary Outcome Measures :
  1. Change in edema quantity at 30th postoperative day [ Time Frame: The measurement is assessed at 1st, 15th and 30th post-operative days. ]

    Quantity of edema is measured in millimetres, through ultrasound scan. The verification of the effectiveness of elastic tape in terms of reduction of edema will be performed through ultrasound.

    During the ultrasound acquisition patients are indicated to assume the supine position on the couch, with 45 ° of humerus flexion and abduction, supported by an operator . Five points of maximum thickness of skin and subcutaneous tissue (edema) will be detected : retroareolar space, Upper-outer quadrant, Upper-inner quadrant, Lower-outer quadrant and Lower-inner quadrant. The thickness will be measured in millimeters.


  2. Change in seroma quantity at 30th postoperative day [ Time Frame: The measurement is assessed at 15th and 30th post-operative days. ]

    Quantity of seroma is measured in millimetres, through ultrasound scan. The verification of the effectiveness of elastic tape in terms of resolution of seroma will be performed through ultrasound.

    During the ultrasound acquisition patients are indicated to assume the supine position on the couch, with 45 ° of humerus flexion and abduction, supported by an operator . Five points of maximum thickness of liquid (seroma) will be detected : retroareolar space, Upper-outer quadrant, Upper-inner quadrant, Lower-outer quadrant and Lower-inner quadrant. The thickness will be measured in millimeters.



Secondary Outcome Measures :
  1. Quality of the scar [ Time Frame: The measurement is assessed at 1st and 30th post-operative days. ]
    The surgeon will make the evaluation of the quality of the scar using the Vancouver Scar Scale. The scale includes the following subscales: Pigmentation (M) in which the best score is "0 = normal" and the worst is "2= Hyperpigmented" , Pliability (P) in which the best score is "0 = normal" and the worst "5 = contracture", Height (H) in which the best score is " 0 = flat" and the worst is "3 = > 5 mm" and Vascularity (V) in which the best score is "0 = normal" and the worst is "3 = purple. The subscales' scores are summed to compute a total score, where lower values represent a better quality of the scar.

  2. Subjective perception of pain [ Time Frame: The measurement is assessed at 1st,15th and 30th post-operative days. ]
    The subjective perception of pain will be measured using Visual Analogue Scale for Pain. It is a measurement tool mainly used to indicate subjective pain characteristics. It consists of a strip of 10 cm in which its extremities correspond respectively to " 0 = no pain", "10 = worst pain that I can imagine", where lower values indicate a good subjective perception of pain. The health professional asks the patient to mark the pain perceived at that moment on the scale.

  3. Degree of patient satisfaction [ Time Frame: The measurement is assessed at 15th and 30th post-operative days. ]
    The degree of patient satisfaction will be measured using Visual Analogue Scale. It consists of a strip of 10 cm in which its extremities correspond respectively to "0 = no satisfaction", "10 = maximum satisfaction", where higher values indicate a good degree of satisfaction. The health professional asks the patient to mark the satisfaction perceived at that moment on the scale.

  4. Degree of disability [ Time Frame: The measurement is assessed at 1st, 15th and 30th post-operative days. ]

    The degree of disability will be measured using DASH scale (The Disability of the Arm, Shoulder and Hand). It is a questionnaire concerning symptoms and abilities to perform certain activities that mainly require the use of the upper limb. For each subscale (30 items) the best score is "1 = no difficulty" and the worst is "5 = unable". The patient is asked to assign a score from 1 to 5 for each activity reported by referring only to the operated side. For the activities contraindicated by the surgeon patients are suggested to give score 5, "unable".

    On the 15th and 30th post-operative day the questions related to the activities of daily life refer to the past week, while on the 1st post-operative day the patients are required to consider the time passed since the intervention. The subscales' scores are summed to compute a total score, where lower values represent a lower degree of disability.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients aged ≥ 18;
  • Complex reconstructive breast surgery with expander or prosthesis;
  • Conditions favoring the correct execution of the proposed program (ability to complete the questionnaires);
  • Written informed consent adherence.

Exclusion Criteria:

  • Patients with psychic or other disorders that may prevent the completion of the questionnaires and / or informed consent adherence;
  • Deferred breast reconstruction;
  • Bilateral breast surgery reconstruction;
  • Previous laterocervical emptying surgery;
  • Maintenance of the surgical drainage for more than 8 days;
  • Acute infections in other parts of the body.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477565


Contacts
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Contact: Stefano Martella 0226436622 martella.stefano@hsr.it

Locations
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Italy
IRCCSSRaffaele
Milan, Italy, 20132
Contact: Stefano Martella    0226436622    martella.stefano@hsr.it   
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
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Principal Investigator: Stefano Martella IRCCS San Raffaele
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Responsible Party: Stefano Martella, Primary Doctor of General Reconstructive Surgery Operating Unit., IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03477565    
Other Study ID Numbers: TAP_Sett17
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Edema
Seroma
Inflammation
Pathologic Processes